I. Field of the Invention
The invention relates to pharmaceutical capsules containing an agent. In particular, the invention is directed to pharmaceutical capsules which are tamper evident.
II. Description of the Prior Art
In recent years the tampering with pharmaceutical capsules has become a nationwide concern and a new form of terrorism. A portion of the pharmaceutical agent is removed and a lethal dosage of poison is substituted. In the alternative, the foreign compound is injected into the capsule by means of a syringe. The unsuspecting victim orally injects the capsule and dies. Catching the perpetrator of the crime is almost impossible.
Many manufacturers at great expense have succumbed to the terrorists and stopped manufacturing products in the capsule form. Thus, depriving the public of a popular form of drug treatment. Other manufacturers have attempted to market their products in tamper-proof packaging.
One common method of protecting the capsules is by sealing the packaging cartons and bottles. This method has the obvious disadvantage that the container can be difficult to open. Also, sealing the closure is often an expensive process.
Two other methods involve sealing the capsule joint. These involve placing a gelatin band around the joint or welding the joint. Welding techniques include heat, ultrasonic or the use of a water mixture to form an adhesive seal. None of these methods preclude the tampering of the capsule by injection of a foreign compound by use of a needle.
Coating of tablets is well known in the art. However, such coatings which contain between 2-4% solids are not designed to exhibit tamper evident characteristics since tampering of tablets has not been found to be a problem. Also, capsules have been coated for limited purposes. These coatings decrease the product tackiness, or aid in retaining the product gloss or facilitate the insertion a rectal suppository. None of these coatings produce a capsule with tamper evident qualities.
The present invention is advantageous for a number of reasons. First, it provides a means for the consumer to visually identify tampered capsules. Second, it provides a means of completely sealing a capsule. Thirdly, the method of the invention is very economical and does not diminish or substantially alter the effectiveness of the capsule and agent inside the capsule. Fourth, the invention provides a means of preventing tampering either by separating the capsule into two sections or through injection. And, fifth, the invention permits the use of products developed and/or approved by the FDA for marketing in capsule form to continue to be marketed without a major reformulation or development of a different dosage form.